Extended Varenicline Treatment for Smoking Among Cancer Patients

Varenicline was used in accordance with FDA approved labeling: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).

On Day 85, participants randomized to standard therapy will be given placebo pills (resembling the 1.0mg pills),

"Behavioral Counseling (from Week 0 - Week 18)~The counseling protocol was based on PHS guidelines for smoking cessation treatment (Fiore et al., 2008), used in our past studies with cancer patients (Schnoll et al., 2010a) and in our ongoing cessation trial at NU (R01 DA025078). Counseling is included given its efficacy at helping smokers quit (Fiore et al., 2008) and to increase study retention. Counseling is provided to both treatment arms through Week 18 to equate for time and attention across arms and since this method was used in varenicline clinical trials (Gonzales et al., 2006) and in our extended therapy trial (Schnoll et al., 2010b). In-person counseling was selected for most sessions to ensure adequate monitoring of participant safety and adherence throughout the trial."